FDA NDA · NDA019790

DILATRATE-SR

Sponsor: ENDO OPERATIONS

APPLICATION

NDA019790

TYPE

NDA

ORIGINAL APPROVAL

1988-09-02

LATEST ACTION

2014-10-24

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Discontinued

Products

DILATRATE-SR · ReferenceDiscontinued

ISOSORBIDE DINITRATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL

2014-10-24Labeling · Supplement 11 · standard — Letter ↗AP

2002-01-30Labeling · Supplement 9 · standardAP

1999-10-29Manufacturing (CMC) · Supplement 8 · standardAP

1999-01-13Labeling · Supplement 7 · standardAP

1998-07-09Manufacturing (CMC) · Supplement 6 · standardAP

1996-05-31Manufacturing (CMC) · Supplement 5 · standardAP

1996-03-13Labeling · Supplement 3AP

1996-03-12Manufacturing (CMC) · Supplement 4 · standardAP

1991-12-09Manufacturing (CMC) · Supplement 2 · standardAP

1991-08-20Manufacturing (CMC) · Supplement 1 · standardAP

1988-09-02Type 5 - New Formulation or New Manufacturer · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.